Trial Outcomes & Findings for Clobetasol Propionate 0.05% Shampoo in Association With Antifungal Shampoo in Scalp Seborrheic Dermatitis (NCT NCT00862654)
NCT ID: NCT00862654
Last Updated: 2021-02-18
Results Overview
Total Severity Score (TSS) is sum of erythema, scaling and pruritus severity scores of the lesions evaluated each on a 4-point scale from 0 = None to 3 = Severe by the investigator. So minimum TSS can be 0 and maximum 9.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
326 participants
Primary outcome timeframe
baseline and week 4
Results posted on
2021-02-18
Participant Flow
Participant milestones
| Measure |
C Propionate 4/Week + Ketoconazole 2/Week
Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
|
C Propionate 2/Week + Ketoconazole 2/Week
Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
|
C Propionate 2/Week
Clobetasol propionate shampoo 0.05% (2/week)
|
Ketakonazol 2/Week
Ketoconazole shampoo 2% (2/week)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
82
|
82
|
82
|
80
|
|
Overall Study
COMPLETED
|
76
|
74
|
76
|
74
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
6
|
6
|
Reasons for withdrawal
| Measure |
C Propionate 4/Week + Ketoconazole 2/Week
Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
|
C Propionate 2/Week + Ketoconazole 2/Week
Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
|
C Propionate 2/Week
Clobetasol propionate shampoo 0.05% (2/week)
|
Ketakonazol 2/Week
Ketoconazole shampoo 2% (2/week)
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
1
|
3
|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
|
Overall Study
Pregnancy
|
1
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
2
|
3
|
|
Overall Study
Subject mistake
|
0
|
1
|
0
|
0
|
|
Overall Study
Familly constraint
|
0
|
1
|
0
|
0
|
|
Overall Study
Never used study drugs
|
1
|
0
|
0
|
0
|
|
Overall Study
Included after end of inclusions
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Clobetasol Propionate 0.05% Shampoo in Association With Antifungal Shampoo in Scalp Seborrheic Dermatitis
Baseline characteristics by cohort
| Measure |
C Propionate 4/Week + Ketoconazole 2/Week
n=82 Participants
Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
|
C Propionate 2/Week + Ketoconazole 2/Week
n=82 Participants
Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
|
C Propionate 2/Week
n=82 Participants
Clobetasol propionate shampoo 0.05% (2/week)
|
Ketakonazol 2/Week
n=80 Participants
Ketoconazole shampoo 2% (2/week)
|
Total
n=326 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
65 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
271 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Age, Continuous
|
46.9 years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
43.8 years
STANDARD_DEVIATION 17.2 • n=7 Participants
|
44.9 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
44.7 years
STANDARD_DEVIATION 15.5 • n=4 Participants
|
45.1 years
STANDARD_DEVIATION 16.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
149 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
177 Participants
n=21 Participants
|
|
Region of Enrollment
France
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
12 participants
n=5 Participants
|
12 participants
n=4 Participants
|
47 participants
n=21 Participants
|
|
Region of Enrollment
Mexico
|
17 participants
n=5 Participants
|
18 participants
n=7 Participants
|
18 participants
n=5 Participants
|
17 participants
n=4 Participants
|
70 participants
n=21 Participants
|
|
Region of Enrollment
Belgium
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
8 participants
n=4 Participants
|
33 participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
35 participants
n=5 Participants
|
37 participants
n=7 Participants
|
34 participants
n=5 Participants
|
34 participants
n=4 Participants
|
140 participants
n=21 Participants
|
|
Region of Enrollment
Korea, Republic of
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
9 participants
n=4 Participants
|
36 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: baseline and week 4Population: Intent To Treat (ITT) with Last Observation Carried Forward (LOCF)
Total Severity Score (TSS) is sum of erythema, scaling and pruritus severity scores of the lesions evaluated each on a 4-point scale from 0 = None to 3 = Severe by the investigator. So minimum TSS can be 0 and maximum 9.
Outcome measures
| Measure |
C Propionate 4/Week + Ketoconazole 2/Week
n=82 Participants
Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
|
C Propionate 2/Week + Ketoconazole 2/Week
n=82 Participants
Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
|
C Propionate 2/Week
n=82 Participants
Clobetasol propionate shampoo 0.05% (2/week)
|
Ketakonazol 2/Week
n=80 Participants
Ketoconazole shampoo 2% (2/week)
|
|---|---|---|---|---|
|
Total Severity Score (TSS): Percent Change From Baseline at Week 4
|
-71.4 Percent change
Interval -100.0 to 14.3
|
-66.7 Percent change
Interval -100.0 to 0.0
|
-66.7 Percent change
Interval -100.0 to 0.0
|
-57.1 Percent change
Interval -100.0 to 33.3
|
Adverse Events
C Propionate 4/Week + Ketoconazole 2/Week
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
C Propionate 2/Week + Ketoconazole 2/Week
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
C Propionate 2/Week
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Ketakonazol 2/Week
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
C Propionate 4/Week + Ketoconazole 2/Week
n=82 participants at risk
Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
|
C Propionate 2/Week + Ketoconazole 2/Week
n=82 participants at risk
Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
|
C Propionate 2/Week
n=82 participants at risk
Clobetasol propionate shampoo 0.05% (2/week)
|
Ketakonazol 2/Week
n=80 participants at risk
Ketoconazole shampoo 2% (2/week)
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/82 • During the study - 12 weeks
|
0.00%
0/82 • During the study - 12 weeks
|
1.2%
1/82 • Number of events 1 • During the study - 12 weeks
|
0.00%
0/80 • During the study - 12 weeks
|
|
Cardiac disorders
ANGINA PECTORIS
|
1.2%
1/82 • Number of events 1 • During the study - 12 weeks
|
0.00%
0/82 • During the study - 12 weeks
|
0.00%
0/82 • During the study - 12 weeks
|
0.00%
0/80 • During the study - 12 weeks
|
Other adverse events
| Measure |
C Propionate 4/Week + Ketoconazole 2/Week
n=82 participants at risk
Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
|
C Propionate 2/Week + Ketoconazole 2/Week
n=82 participants at risk
Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
|
C Propionate 2/Week
n=82 participants at risk
Clobetasol propionate shampoo 0.05% (2/week)
|
Ketakonazol 2/Week
n=80 participants at risk
Ketoconazole shampoo 2% (2/week)
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
1.2%
1/82 • Number of events 1 • During the study - 12 weeks
|
1.2%
1/82 • Number of events 1 • During the study - 12 weeks
|
2.4%
2/82 • Number of events 2 • During the study - 12 weeks
|
1.2%
1/80 • Number of events 1 • During the study - 12 weeks
|
|
Infections and infestations
Dengue fever
|
0.00%
0/82 • During the study - 12 weeks
|
0.00%
0/82 • During the study - 12 weeks
|
2.4%
2/82 • Number of events 2 • During the study - 12 weeks
|
0.00%
0/80 • During the study - 12 weeks
|
|
Reproductive system and breast disorders
Dymenorrhoea
|
2.4%
2/82 • Number of events 3 • During the study - 12 weeks
|
0.00%
0/82 • During the study - 12 weeks
|
0.00%
0/82 • During the study - 12 weeks
|
0.00%
0/80 • During the study - 12 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/82 • During the study - 12 weeks
|
2.4%
2/82 • Number of events 2 • During the study - 12 weeks
|
0.00%
0/82 • During the study - 12 weeks
|
2.5%
2/80 • Number of events 3 • During the study - 12 weeks
|
|
Infections and infestations
Influenza
|
3.7%
3/82 • Number of events 3 • During the study - 12 weeks
|
4.9%
4/82 • Number of events 4 • During the study - 12 weeks
|
2.4%
2/82 • Number of events 2 • During the study - 12 weeks
|
1.2%
1/80 • Number of events 1 • During the study - 12 weeks
|
|
Infections and infestations
Nasopharyngitis
|
6.1%
5/82 • Number of events 6 • During the study - 12 weeks
|
4.9%
4/82 • Number of events 4 • During the study - 12 weeks
|
8.5%
7/82 • Number of events 7 • During the study - 12 weeks
|
6.2%
5/80 • Number of events 7 • During the study - 12 weeks
|
|
Infections and infestations
Pharyngitis
|
2.4%
2/82 • Number of events 3 • During the study - 12 weeks
|
1.2%
1/82 • Number of events 1 • During the study - 12 weeks
|
2.4%
2/82 • Number of events 2 • During the study - 12 weeks
|
2.5%
2/80 • Number of events 2 • During the study - 12 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/82 • During the study - 12 weeks
|
3.7%
3/82 • Number of events 4 • During the study - 12 weeks
|
1.2%
1/82 • Number of events 1 • During the study - 12 weeks
|
0.00%
0/80 • During the study - 12 weeks
|
|
Infections and infestations
Respiratory Tract Infection
|
1.2%
1/82 • Number of events 1 • During the study - 12 weeks
|
2.4%
2/82 • Number of events 2 • During the study - 12 weeks
|
0.00%
0/82 • During the study - 12 weeks
|
1.2%
1/80 • Number of events 1 • During the study - 12 weeks
|
|
Infections and infestations
Rhinitis
|
0.00%
0/82 • During the study - 12 weeks
|
1.2%
1/82 • Number of events 1 • During the study - 12 weeks
|
1.2%
1/82 • Number of events 1 • During the study - 12 weeks
|
2.5%
2/80 • Number of events 2 • During the study - 12 weeks
|
|
Infections and infestations
Sinusitis
|
1.2%
1/82 • Number of events 1 • During the study - 12 weeks
|
0.00%
0/82 • During the study - 12 weeks
|
0.00%
0/82 • During the study - 12 weeks
|
2.5%
2/80 • Number of events 2 • During the study - 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any intent of the investigator to publish or disclose in any way the information requires the sponsor's prior written approval. The investigator shall provide their draft of such publication to sponsor to review and approval at least 2 months prior to the date of intended publication. Sponsor shall have the absolute right to determine whether information may be published by the investigator.
- Publication restrictions are in place
Restriction type: OTHER